BLA 050294

PARKE DAVIS

FDA Drug Application

Application #050294

Documents

• Other: 2020-03-23

Application Sponsors

BLA 050294

PARKE DAVIS

Marketing Status

• Discontinued: 001

Application Products

001

OINTMENT;TOPICAL

10MG/GM;666 UNITS/GM;1 UNITS/GM

0

ELASE-CHLOROMYCETIN

CHLORAMPHENICOL; DESOXYRIBONUCLEASE; FIBRINOLYSIN

FDA Submissions

UNKNOWN;	ORIG	1	AP	1964-04-01	UNKNOWN
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1983-07-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1986-09-26
LABELING; Labeling	SUPPL	4	AP	1988-04-21
LABELING; Labeling	SUPPL	5	AP	1964-04-14
LABELING; Labeling	SUPPL	6	AP	1964-04-14
LABELING; Labeling	SUPPL	8	AP	1967-04-24
LABELING; Labeling	SUPPL	9	AP	1970-01-21
LABELING; Labeling	SUPPL	10	AP	1990-11-06
LABELING; Labeling	SUPPL	11	AP	1971-12-13
LABELING; Labeling	SUPPL	12	AP	1973-05-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1974-10-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1975-06-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1977-02-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1978-06-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1978-06-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1978-06-06
LABELING; Labeling	SUPPL	19	AP	1978-09-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1979-12-20
LABELING; Labeling	SUPPL	21	AP	1980-09-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	1997-04-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	1998-01-08

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	17	Null	0
SUPPL	18	Null	0
SUPPL	20	Null	0
SUPPL	22	Null	0
SUPPL	24	Null	0

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 50294
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)